UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014202 |
|---|---|
| Receipt number | R000016536 |
| Scientific Title | A phaseII study of nab-paclitaxef in patients with pretreated advanced non-small-cell lung cancer. |
| Date of disclosure of the study information | 2014/06/09 |
| Last modified on | 2017/08/21 08:29:16 |
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Basic information
Public title
A phaseII study of nab-paclitaxef in patients with pretreated advanced non-small-cell lung cancer.
Acronym
A phaseII study of nab-paclitaxef in patients with pretreated advanced non-small-cell lung cancer.
Scientific Title
A phaseII study of nab-paclitaxef in patients with pretreated advanced non-small-cell lung cancer.
Scientific Title:Acronym
A phaseII study of nab-paclitaxef in patients with pretreated advanced non-small-cell lung cancer.
Region
| Japan |
Condition
Condition
Non-Small-Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and efficacy of nab-paclitaxel in patients with pretreated advanced non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
progression free survival
Key secondary outcomes
Progression free survival, Overall Survival, Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nab-paclitaxel 100mg/m2
Day1,8,15
Every four weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven stage IIIB/IV non-small cell lung cancer
2) Pretreated with one regimen.
3) ECOG PS : 0-2
4) chemo naïve
5) Adequate organ function
6) Age: 20- years old
7) At least one measurable lesion by RECIST
8)without other active double cancer.
9) Life expectancy more than three months
10) Written informed consent
Key exclusion criteria
1)With severe myelosupression.
2) With active infectious disease
3) Interstitial pneumonia or pulmonary fibrosis detectable on X ray
4)History of cardiac dysfunction
5)History of treatment with paclitaxel.
6)History of albumin sensitivity
7)Symptomatic brain metastasis
8)Pericardial or pleural effusion requiring drainage
9) History of serious disease condition
10) History of drug allergy
11) With pregnancy or lactation
12) Without measurable lesion by RECIST
13) With grade2 or more neuropathy
14) Evaluated to be ineligible by a physician for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayasu Kurata |
Organization
Kansai Medical University Hirakata Hospital
Division name
Thoracic oncology
Zip code
Address
2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL
072-804-0101
kuratat@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yokoi |
Organization
Kansai Medical University Hirakata Hospital
Division name
Thoracic oncology
Zip code
Address
2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL
072-804-0101
Homepage URL
yokoit@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Hirakata Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 07 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016536
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
